Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 9:17 PM
Ignite Modification Date: 2025-12-25 @ 7:05 PM
NCT ID: NCT02704104
Description: Adverse events were assessed immediately after treatment (Day 0), Day 7, and Day 30.
Frequency Threshold: 3
Time Frame: 30 days
Study: NCT02704104
Study Brief: Safety and Performance Evaluation of the Topical Hemostatic Device (AC5™) Following Excision of Skin Lesions
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Control The intervention in this arm is the application of saline (Control) to a freshly excised skin lesion AC5 Hemostatic agent: Randomized application of the hemostatic agent AC5 to one of two freshly excised lesions in each patient 0 None 0 46 13 46 View
AC5 Topical Hemostatic Device The intervention in this arm is the application of a topical hemostatic agent (AC5) to a freshly excised skin lesion AC5 Hemostatic agent: Randomized application of the hemostatic agent AC5 to one of two freshly excised lesions in each patient 0 None 0 46 13 46 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Wound complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (10.0) View
Secretion discharge SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Fibrin D dimer increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (10.0) View
Wound hemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (10.0) View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (10.0) View